Clot Removal Device and Method of Using Same

ABSTRACT

A minimally invasive endovascular device for treating a blocked or obstructed biological lumen, such as a blood vessel fully or partially obstructed by deposits of biological matters in or non-biological matters. Certain embodiments of the present invention comprise two capture members that are configured to be placed on either side of the obstruction and enclose around the obstruction for removal. Embodiments of the present invention also provide methods for implementing an endovascular device according to aspects of the present invention.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application No.61/688,784, filed on May 21, 2012, the disclosure of which isincorporated by reference.

TECHNICAL FIELD

Embodiments of the present invention relate generally to medical devicesand methods of using same, and more specifically, to medical devices fortreating or treating an occluded biological lumen, such as an embolus orclot in a blood vessel.

BACKGROUND OF THE INVENTION

This section is intended to introduce various aspects of the art, whichmay be associated with exemplary embodiments of the present invention.This discussion is believed to assist in providing a framework tofacilitate a better understanding of particular aspects of the presentinvention. Accordingly, it should be understood that this section shouldbe read in this light, and not necessarily as any admission of priorart.

There are many reasons a blood vessel becomes blocked or obstructed. Onecommon way is from deposition of thrombus or clot inside the lumen ofthe blood vessels which can restrict the antegrade blood flow throughthe lumens of these blood vessels to the body tissues. Because arterialblockages reduce blood flow through the affected vessel, any blockage orobstruction can lead to many serious medical complications as tissuerelying on the blood's supply of oxygen may become damaged due to thedecrease in the oxygen amount. For instance in the brain circulationthis can lead to stroke with loss of vital brain functions and/or death,while in the heart it can lead heart attack due to damage of the heartmuscle with significant impairment of its ability to pump blood to thebody organ which can eventually lead to death.

While various methods and devices are available to treat a blockage orobstruction through removal of the obstructing clot, these devices canbe traumatic to the blood vessel due to stiffness and pressure exertedon the lining of the vessel during clot engagement and removal. Inaddition, they usually do not sufficiently capture and retain theparticulate matters from the obstruction. In particular, these methodsusually cause fragmentation of the clot either during device engagementof the clot or due to the friction between the not fully encapsulatedclot with the wall of the vessels or the flowing blood during theremoval from the body. This fragmentation of the clot can lead tomigrating of clot fragments with the blood flow either to the sametreated blood vessels and its branches distal to the originalobstruction site or to another unaffected area of the vascular system inthe branching circulation at or proximal to the site of the obstructionwhere they can get lodged again and causes further obstruction. Thereremain a need for new devices to safely remove the obstructing clotfully encapsulated and shielded from the friction force with the bloodvessel wall and the flowing blood to prevent excessive fragmentation anddistal migration

BRIEF SUMMARY OF THE INVENTION

Embodiments of the present invention provides a minimally invasiveendovascular device for treating a blocked or obstructed biologicallumen, such as a blood vessel fully or partially obstructed by depositsof biological matters in or non-biological matters. Certain embodimentsof the present invention comprise two capture members that areconfigured to be placed on either side of the obstruction and enclosearound the obstruction for removal. Embodiments of the present inventionalso provide methods for implementing an endovascular device accordingto aspects of the present invention.

According to one aspect of the present invention, a device to remove anobstruction in a lumen is described. The device comprises a firstcapture member, a second capture member, where each capture membercomprises an open end and a tapered end. The open end is defined by aframe component coupled to a body component, the body componentextending between the open end and the tapered end. The device furthercomprises a first guide member coupled to the first capture member atthe open end, where at least a portion of the body component is attachedto the first guide member, and a second guide member coupled to thesecond capture member at the open, where at least a portion of the bodycomponent is attached to the second guide member, where the firstcapture member and the second capture member are slidably coupled toeach other, the slidable coupling comprises the first guide memberdisposed in the second guide member.

In one embodiment, the device further comprises a radiopaque marker. Inanother embodiment, the frame component is configured to fit within acatheter for delivery to the obstruction and to expand to define theopen end when released from the catheter, the catheter having a radiussmaller than a radius of the open end. In one embodiment, the framecomponent comprises a self-expanding material configured to have anoriginal configuration and a deformed configuration; where theself-expanding material is configured to change from the deformedconfiguration to the original configuration at least by exposure to anactivating condition. In another embodiment, the deformed configurationallows the device to fit within the catheter.

In one embodiment, the body component is attached to the respectiveguide member substantially along the length of the body component. Inanother embodiment, at least one capture member further comprises asupport arm coupled to the respective guide member and the respectiveframe component. In one embodiment, the support arm comprises a firstend and a second end, where the first end is coupled to the respectiveframe component and the second end is coupled to the respective guidemember. In another embodiment, the second end is attached to therespective guide member. In another embodiment, the respective guidemember further comprises a fastening member slidably coupled to therespective guide member and where the second end is attached to thefastening member.

In one embodiment, the body component is fluid impermeable. In anotherembodiment, the body component comprises a woven material of at leastone of the following: a polymer, a methal, and any combination thereof.In another embodiment, the body component covers at least a portion of asurface of the frame component to which the body component is coupled.In another embodiment, at least one guide member is adapted to provide asuctioning force.

In one embodiment, the diameter of one frame component is smaller thanthe diameter of the other frame component. In another embodiment, atleast one frame component comprises an inflatable member. In anotherembodiment, the device further comprises an inflatable member disposednear at least one frame component.

In one embodiment, at least one guide member comprises a body with achannel disposed therein, the body having at least one aperturepositioned near an end near the respective capture member. In oneembodiment, the guide member is used to provide a suctioning force. Inone embodiment, the guide member is used to deliver a therapeuticsubstance to the obstruction. In another embodiment, the couplingbetween at least one guide member and the respective frame membercomprises the at least one guide member attached to an outer surface ofthe respective frame member.

According to another aspect of the present invention, there is provideda method for removing an obstruction in a lumen. The method comprisesthe steps of delivering an endovascular device to the location of theobstruction in a patient using a catheter, where the device comprises afirst capture member and a second capture member, where each capturemember comprises an open end and a tapered end, where the open endcomprises a frame component coupled to a body component, the bodycomponent extending between the open end and the tapered end. The devicefurther comprises a first guide member coupled to the first capturemember at the open end and along at least a portion of the bodycomponent, and a second guide member coupled to the second capturemember at the open end and along at least a portion of the bodycomponent, where the first capture member and the second capture memberare slidably coupled to each other, the slidable coupling comprises thefirst guide member disposed in the second guide member. The methodfurther comprises the steps of positioning a distal end of the catheterdistal to the obstruction, withdrawing the catheter to release the firstcapture member distal to the obstruction; positioning the distal end ofthe catheter proximal to the obstruction; withdrawing the catheter torelease the second capture member proximal to the obstruction; enclosingthe obstruction with the capture members by manipulating at least one ofthe first guide member or the second guide member to unite the capturemembers; and removing the captured obstruction by removing the unitedcapture members from the lumen.

In one embodiment, the method further comprises the step of providing asuctioning force through at least one guide member. In anotherembodiment, the method further comprises the step of repeatedly movingat least one frame member against the obstruction. In anotherembodiment, the method further comprises the step of delivering atherapeutic substance to the obstruction. In one embodiment, thedelivering is achieved at least through one of the guide members, theguide member comprising a body with a channel disposed therein, the bodyhaving at least one aperture positioned near an end near the respectivecapture member.

In one embodiment, the enclosing step comprises manipulating the firstguide member to engage a surface of the first capture member with asurface of the obstruction while the second guide member is maintainedstationary. In another embodiment, the enclosing step comprisesmanipulating the second guide member to engage a surface of the secondcapture member with a surface of the obstruction while the first guidemember is maintained stationary. In another embodiment, the enclosingstep comprises manipulating both the first and second guide members toengage a surface of both capture members with a surface of theobstruction.

The foregoing has outlined rather broadly the features and technicaladvantages of the embodiments of the present disclosure in order thatthe detailed description of these embodiments that follows may be betterunderstood. Additional features and advantages of the embodiments of thepresent disclosure will be described hereinafter which form the subjectof the claims of the present disclosure. It should be appreciated bythose skilled in the art that the conception and specific embodimentdisclosed may be readily utilized as a basis for modifying or designingother structures for carrying out the same purposes of the presentdisclosure. It should also be realized by those skilled in the art thatsuch equivalent constructions do not depart from the spirit and scope ofthe present disclosure as set forth in the appended claims. The novelfeatures which are believed to be characteristic of the presentdisclosure, both as to its organization and method of operation,together with further objects and advantages will be better understoodfrom the following description when considered in connection with theaccompanying figures. It is to be expressly understood, however, thateach of the figures is provided for the purpose of illustration anddescription only and is not intended as a definition of the limits ofthe present disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of the embodiments of the presentinvention, reference is now made to the following descriptions taken inconjunction with the accompanying drawing, in which:

FIGS. 1A-1C illustrate side perspective views of certain exemplarystages in an exemplary embodiment of a procedure for using a firstembodiment of the endovascular device according to certain aspects ofthe present invention.

FIG. 2 illustrates a perspective view of the first embodiment of theendovascular device according to certain aspects of the presentinvention in a closed configuration traveling through a blood vessel;and

FIG. 3 illustrates a perspective side view of the first embodiment ofthe endovascular device according to certain aspects of the presentinvention in a closed configuration entering a catheter;

FIGS. 4A-4D illustrate side perspective views of certain exemplarystages in an exemplary embodiment of a procedure for using a secondembodiment of the endovascular device according to certain aspects ofthe present invention;

FIG. 5 illustrates a perspective side view of the second embodiment ofthe endovascular device according to certain aspects of the presentinvention in a closed configuration entering a catheter;

FIGS. 6A and 6B illustrate side perspective views of a third embodimentof capture members of the endovascular device according to certainaspects of the present invention;

FIG. 7 illustrates a side perspective view of the capture members ofFIG. 6A coupled to one another; and

FIGS. 8A-8F are side perspective views of certain exemplary stages in anexemplary embodiment of a procedure for using the endovascular deviceshown in FIG. 7 according to certain aspects of the present invention.

It should be understood that the drawings are not necessarily to scaleand that the disclosed embodiments are sometimes illustrateddiagrammatically and in partial views. In certain instances, detailswhich are not necessary for an understanding of the disclosed methodsand apparatuses or which render other details difficult to perceive mayhave been omitted. Also, for simplification purposes, there may be onlyone exemplary instance, rather than all, is labeled. It should beunderstood, of course, that this disclosure is not limited to theparticular embodiments illustrated herein.

DETAILED DESCRIPTION OF THE INVENTION

Embodiments of the present invention provide for minimally invasiveremoval of obstructing material, such as a clot or embolism, disposed ina patient's (human or otherwise) vascular system. Certain embodiments ofthe present invention are particularly applicable for extraction ofmaterial in small, tortuous and highly branching segments of theneurovascular system. In a general embodiment, the endovascular deviceof the present invention includes two opposing capture members that areslidably coupled to each other. Each capture member preferably comprisesan open end and a tapered end, where the open end of each capture memberfaces one another. In one embodiment, the endovascular device can bedelivered to the site of the material deposit using a catheter. Thecapture members can be placed on each side of the material deposit withthe open ends facing the material deposit. In one embodiment, the openend of each capture member is supported by a frame component. In anotherembodiment, the capture members are slidably coupled to one another toallow the capture members to move in the distal and proximal directionsto facilitate in dislodging the clot from the arterial wall. In apreferred embodiment, the majority of the material deposit is moved intothe capture members at the site of lodging when the capture membersencloses the clot as they progress toward one another. In one closedconfiguration, the open end of the capture members meet one another toform an enclosure to capture and retain the material deposit containedtherein. The capture members can be withdrawn in this closedconfiguration and/or be pulled into a catheter, thereby removing thematerial deposit. Embodiments of the present invention provide for clotremoval without excessive force or compression of the clot, therebyminimizing fragmentation of the clot or squeezing of the clot into sidebranches that may exist at the site of obstruction, which can lead tofurther damage.

FIGS. 1-3 show certain specific embodiments according to the aspects ofthe present invention. FIGS. 1A-1C show capture members 102 and 104 ofendovascular device 100 in a fully expanded configuration. Capturemember 102 is the proximal capture member while capture member 104 isthe distal member with respect to obstruction 114. In one embodiment,capture members 102 and 104 substantially resemble each other, eachcomprising open end 106, tapered end 108, and body component 110extending between open end 106 and tapered end 108. Open end 106preferably comprises open end support member or frame component 112defining the shape and size of open end 106 when capture members 102 and104 are expanded. Frame component 112 preferably has a circular shapethat matches the shape of the target blood vessel. In other embodiments,however, frame component 112 can have any shape in the expandedconfiguration desired, such as circular, oval, rectangular or any otherregular or irregular shapes that may be suitable to the particularapplication.

In one embodiment, frame component 112 comprises a self-expandingmaterial including, but not limited to, a metal, an alloy, a composite,a polymer, and the like. In one non-limiting example, frame component112 comprises nitinol, stainless steel, cobalt chromium, platinum,titanium, plastic, or any combination thereof. In another embodiment,frame component 112 comprises a superelastic and/or self-expandingmaterial with properties that allow it to have a deformed shape underone condition and to recover its original shape prior to deformation,which can also be referred to as an expanded configuration. Anon-limiting example is a memory-shaped heated alloy such as nitinol, ornickel titanium, which is a metal alloy of nickel and titanium. Nitinolalloys exhibit two closely related and unique properties: shape memoryand superelasticity. Shape memory refers to the ability of nitinol toundergo deformation at one temperature, then recover its original,un-deformed shape upon heating above its “transformation temperature.”That is, nitinol alloy has a biased expanded condition and may becompressed into a collapsed or deformed condition before use. Duringuse, it may be exposed to temperature above the transformationthreshold, thereby causing it to revert back to its un-deformed and/ororiginal shape. Frame component 112 can also comprise any flexibleand/or elastic material that allows frame component 112 to becompressed, or deformed by a radial force, to fit into a catheter, suchas catheter 122, without sustaining any damage and revert back to itsoriginal shape once released from the catheter.

In one embodiment, such as that shown in FIGS. 8A-8B, frame component112 has a deformed or compressed shape with a smaller diameter than theun-deformed, expanded shape shown in FIGS. 1A-1C. In one embodiment, thethickness of frame component 112 is in a range between about 10 micronsto 500 microns. In a preferred embodiment, the thickness of framecomponent 112 is in a range between about 80 microns to about 120microns. In another preferred embodiment, the thickness of framecomponent 112 is in a range between about 95 microns to about 105microns.

Referring to FIGS. 1A-1C, in a preferred embodiment, the diameter acrossframe component 112 in an expanded configuration, and thus open end 106,is configured to substantially match the diameter of the particularlumen or blood vessel of interest in which the obstruction, e.g., clot114, is disposed. In such an expanded configuration, frame component 112preferably contacts the inner wall of the target blood vessel gently,e.g., without exerting significant force that can damage the bloodvessel. This allows at least one capture member 102 or 104 to extendacross the interior, or lumen, of the blood vessel where effectivelymost or all obstructing materials are directed through the respectiveextended capture member 102 or 104. In one embodiment, the diameter ofopen end 106 is in a range of about 1.5 mm to about 6 mm, and preferablyin a range of about 2 mm to about 4.5 mm. In another preferredembodiment, the diameter of open end 106 is between about 2.5 mm andabout 3 mm. It is understood that other embodiments can include capturemembers 102 and 104 of different sizes and configurations. For instance,in one embodiment, one capture member has an open end with a smallerdiameter than the other capture member so that one can be inserted intothe other, providing an overlapping area. In another embodiment,endovascular device 100 is provided in various sizes and configurationdepending on the location of the material deposit to be removed.

Referring to FIGS. 1A-1C, in a preferred embodiment, open end 106further comprises one end of body component 110 coupled to framecomponent 112. In such an embodiment, when the respective capturemember, 102 or 104, is released from catheter 112, it expands into theconfiguration shown in FIGS. 1A-1C. In one embodiment, this is achievedwith the expansion of frame component 112, which opens body component110 for material to enter. Body component 110 is preferably formed ofany material which is flexible and compatible with bodily tissues andfluids such as blood. In a preferred embodiment, body component 110 isdevoid of any fenestration, i.e., the material of body component 110 isimpermeable to fluid. Non-limiting examples of suitable materialsinclude polymeric film or fabric-like materials, such as, but notlimited to, polyurethane, polyolefin, polyester, plastic, siliconepolymers, and any combination thereof. In one embodiment, the materialof body component 110 has properties, such as being soft and flexible,that are configured to minimize friction and/or pressure placed on thewall upon contact of the capture members with the lining of the vesselduring implementation of device 100. In an alternative embodiment,tapered end 108 can further include at least one fenestration ofsufficient size to allow fluids to flow through body component 110 whileretaining the captured material deposit. In one embodiment, the materialof body component 110 can comprise a material with self-expandingproperties as described above, providing it a biased shape in theexpanded configuration that allows body component 110 to remain open asit extends away from frame component 112.

Body component 110 can be coupled to frame component 112 in any suitablemanner. In one embodiment, body component 110 can be attached to framecomponent at or near the inner diameter or outer diameter of framecomponent 112. In another embodiment, body component 110 surrounds atleast a portion of frame component 112. In such an embodiment, thematerial of body component 110 contacts the inner wall of the lumen inthe expanded configuration instead of frame component 112, which canhelp protect the inner wall from potential damage or injury resultingfrom contact with frame component 112 itself.

Alternatively, expansion of one capture member, 102 or 104, whenreleased from a catheter can be achieved through mechanical means knownto those skilled in the art. In one embodiment, frame component 112comprises an inflatable member comprising an enclosed fillable volume,such as a balloon, that expands when the member is filled with a fluid.In this embodiment, the inflatable member has the shape of framecomponent 112 as shown, e.g., annular, and body component 110 is coupledto the inflatable frame component. When released from catheter 122,frame component 112 can be expanded by filling the interior of theinflatable member with fluid using methods known to those skilled in theart. The diameter of the inflatable member, and thus, open end 106, canbe adjusted based on the amount of fluid provided to the inflatablemember. In another embodiment, instead of forming frame component 112with an inflatable member, frame component 112 is expanded through theexpansion of an inflatable member. The inflatable member has a shapethat corresponds to the shape of frame component 112 where it can beplaced at or near the respective open end 106 so that the radialexpansion of the inflatable member pushes against the respective framecomponent 112 to expand it. Once the respective frame component isexpanded, the inflated members can be deflated and removed asappropriate. It is understood that other ways of using an inflatableknown to one of ordinary skill in the art can also be used. Other wayscan include the addition of self-expanding wire(s) coupled to the innerwall of at least one capture member in circular pattern, longitudinalpattern, helical pattern, or any combination thereof.

Referring to FIG. 1C, when capture members 102, 104 unite to form onecapture enclosure, the length of the capture enclosure preferably islonger than the length of the target obstruction, e.g., clot 114. In oneembodiment, the total length of both capture members united is betweenabout 5 mm and about 30 mm. In a preferred embodiment, the total lengthof both capture members united is between about 8 mm and about 20. Inanother preferred embodiment, the total length of both capture membersunited is between about 10 mm and 12 mm. In yet another preferredembodiment, the total length of both capture members united is about 10mm.

Referring to FIGS. 1A-1C, capture members 102 and 104 are slidablycoupled to one another with the open ends facing each other, allowingthem to be moved apart or unite to form one enclosure. In a preferredembodiment, distal capture member 104 is coupled to distal guide member116, and proximal capture member 102 is coupled to proximal guide member118. Distal guide member 116 is preferably disposed in proximal guidemember 118. In this configuration, the relative position of capturemembers 102 and 104 can be adjusted in various manners. In oneembodiment, a user can hold proximal guide member 118 constant, therebykeeping proximal capture member 102 in one position, while pushing orpulling distal guide member 116 to adjust the position of distal capturemember 104. In another embodiment, the user can hold distal guide member116 constant, thereby keeping distal capture member 104 in one position,while pushing or pulling proximal guide member 118 to adjust theposition of proximal capture member 102. In yet another embodiment, bothguide members 116 and 118 can be adjusted at the same time to achievethe desired positions of capture members 102 and 104 with respect toeach other. Once capture members 102, 104 are in a desired position,that position can be maintained by attaching guide members 116, 118together, thereby stabilizing endovascular device 100. In oneembodiment, distal guide member 116 comprises a solid body, such as awire; alternative, it can comprise a body with an interior channel, suchas a tube. In a preferred embodiment, proximal guide member 118comprises a tube. In another embodiment, proximal guide member 118 isconfigured with suction capabilities to assist with bringing clot 114into capture member 102 and/or 104. In yet another embodiment, bothguide members 116, 118 comprise a body with a channel disposedtherethrough having at least one aperture on the body, so guide members116,118 can be used to provide a suctioning force. Alternatively, or inaddition to, the at least one aperture on the body of such guide membersin such an embodiment is preferably located near (e.g., at or proximal)clot 114 so that these guide members can also be used to deliver desiredsubstances locally to the site of clot 114. Non-limiting examples ofsubstances that can be delivered include medication configured tofacilitate dislodging and removal of clot 114, such as clot dissolvingmedication that softens and shrinks the clot.

The body of either guide member 116, 118 preferably has a lengthsufficient to extend through the vascular system of a patient to reachthe target accumulation and place endovascular device 100 in the desireddeployment location. In one embodiment, either guide member 116, 118 hasa length of between about 50 cm and about 250 cm, more preferably alength of about 125 cm and about 175 cm. The diameter of either guidemember 116, 118 may be constant or may vary along the length of therespective guide member 116, 118. For example, the diameter of one guidemember toward the proximal end away from the user may be between about0.2 mm and about 1 mm, and preferably about 0.3 mm and about 0.4 mm,while the diameter near the distal end near the clot may be betweenabout 0.05 mm and about 1 mm, and more preferably about 0.1 mm and about0.2 mm. Accordingly, the diameter of either guide member 116, 118 maytaper from the proximal end to the distal end.

Referring to FIGS. 1A-1C, distal capture member 104 is preferablycoupled to distal guide member 116 via frame component 112. In apreferred embodiment, frame component 112 is preferably coupled todistal guide member 116 at an angle of about 90 degrees. In oneembodiment, the angle between guide member 116 and frame component 112can be further supported by at least one additional support arm 120,preferably extending between distal guide member 116 and frame component112. In a preferred embodiment, one end of support arm 120 is coupled tothe respective frame component 112 while the other end of support arm120 a is coupled to guide member 116. In another embodiment, one end ofsupport arm 120 is coupled to the respective frame component 112 and theother end is coupled to a fastening component (not shown) slidablycoupled to guide member 116, allowing the coupling angle of therespective frame component 112 to be adjusted. In one embodiment, oneend of support arm 120 is coupled to distal guide member 116 in a mannerthat allows it to extend in the proximal direction when capture member102 is released from catheter 122. In one embodiment, capture member 102has more than one support arms 120. In another preferred embodiment,body component 110 is attached to distal guide member 116 along at leasta portion of the length of body component 110 or only tapered end 108 iscoupled to distal guide member 116. In yet another embodiment, bodycomponent 110 is coupled to distal guide member 116 from open end 106 totapered end 108, along the length of body component 110.

In a preferred embodiment, each guide member 116, 118 has one attachmentsite to the outer circumference of its respective frame, thereby leavingsubstantially all of the respective frame component 112 and open end 106available for engagement with clot 114. Such a configuration allows foreasier transmission of the captured clot inside device 100 through thetortuous paths with minimal interference from guide members 116, 118 ortheir attachment to frame components 112. Further, this configurationallows the segment of distal guide member 104 to act like a railing uponwhich clot 114 can move inside capture members 102, 104 when distalcapture member 104 is held constant and proximal capture member 102 ispushed.

Proximal capture member 102 is preferably coupled to proximal guidemember 118 in a similar manner. In a preferred embodiment, framecomponent 112 of proximal capture member 102 is preferably coupled toproximal guide member 118 at an angle of about 90 degrees. In oneembodiment, the angle between guide member 118 and capture member 104can be further supported by at least one additional support arm 120 a,preferably extending between proximal guide member 118 and framecomponent 112 of proximal capture member 102. In a preferred embodiment,one end of support arm 120 a is coupled to frame component 112 while theother end of support arm 120 a is coupled to guide member 118. Inanother embodiment, one end of support arm 120 a is coupled to therespective frame component 112 and the other end is coupled to afastening component (not shown) slidably coupled to guide member 118,allowing the coupling angle of the respective frame component 112 to beadjusted. In one embodiment, one end of support arm 120 a is coupled toproximal guide member 118 in a manner that allows it to extend in thedistal direction when proximal capture member 102 is released fromcatheter 122. In another embodiment, capture member 104 has more thanone support arms 120 a. In another embodiment, body component 110 iscoupled to proximal guide member 118 along at least a portion of thelength of body component 110 or only tapered end 108 is coupled toproximal guide member 118. In yet another embodiment, body component 110is attached to proximal guide member 118 from open end 106 to taperedend 108, along the length of body component 110.

In a preferred embodiment, body component 110 of capture members 102 and104 are configured to fully encapsulate clot 114 and prevent migrationof clot 114, thereby reducing the risk of clot 114 from unintentionallyending up at another location in the patient's body. In one embodiment,this is achieved by forming body component 110 of suitable materials donot have any fenestration.

In a preferred embodiment, endovascular device 100 includes at least oneradiopaque portion to facilitate visualization using, for example, oneor more of fluoroscopy, computer tomography (CT) fluoroscopy, or thelike. The radiopaque portion can be a component of endovascular device100. In one embodiment, at least one frame component 112 comprises aradiopaque material. Non-limiting examples of a radiopaque materialinclude platinum or tantalum DFT Nitinol. Referring to FIG. 2, inanother embodiment, a separate radiopaque marker is provided, such asradiopaque component 124 coupled at the junction where frame component112 is coupled to the respective guide member, e.g., distal guide member116. Endovascular device 100 can have one or more than one radiopaquemarker coupled at various positions. For instance, each capture member102, 104 can have its own radiopaque component 124.

Referring to FIGS. 2-3, once all or substantially all of clot 114 iscaptured in the enclosure formed by capture members 102, 104, clot 114can be removed by holding guide members 116, 118 together so they canremain united with one another as a unit and be withdrawn together withclot 114 contained therein. Referring to FIG. 2, capture members 102,104 can be pulled through a stretch of blood vessels as a unitcontaining clot 114 before device 100 enters catheter 126, as shown inFIG. 4, for removal from the patient's body. In the embodiment shown,catheter 126 has a diameter that is larger than the diameter of framecomponents 112.

FIGS. 4A-4D and 5 illustrate another embodiment of the endovasculardevice of the present invention, endovascular device 400. In a preferredembodiment, endovascular device 400 is similar to endovascular device100, except open end 406 of distal capture member 404 is smaller thanopen end 406 of proximal capture member 402. As shown, in oneembodiment, the outer diameter of frame component 412 of distal capturemember 404 is smaller than the outer diameter of frame component 412 ofthe proximal capture member 402. This configuration can help to reduceany opening or gap that can form between both frame components 412 whenthey unite with one another. Other features discussed herein withrespect to endovascular device 100, such as dimensions, materials,strand density, strand diameter, shape, position with respect to theblood vessel interior wall, coupling of guide members, radiopaquemarker, etc., are also applicable to endovascular device 400, and thusneed not be repeated.

Referring to FIG. 5, once all or substantially all of clot 414 iscaptured in the enclosure formed by capture members 402, 404, and clot414 can be removed by holding guide members 416, 418 together so theycan remain united with one another as a unit and be withdrawn togetherwith clot 114 contained therein. The united capture members 402, 404,along with clot 414 can be pulled into catheter 424 for removal.

FIGS. 6A-6B, 7, and 8A-8F illustrate another embodiment of theendovascular device of the present invention, endovascular device 600.In a preferred embodiment, endovascular device 600 is similar toendovascular device 100, except for several features. In the embodimentshown in FIGS. 6A-6B, 7, and 8A-8F, tapered end 608 of capture members602, 604 are not coupled to the respective guide members 616, 618.Referring to FIG. 6B, in another embodiment, body component 610comprises polymeric net-like materials having a plurality offenestrations throughout the material, such as, but not limited to, awoven mesh of polymeric material, metal, and/or other superelastic,self-expanding, and/or memory shape alloy such as nitinol. In certainembodiments, the woven mesh can comprise a combination of polymers,metals, and/or metal alloys. Referring to FIG. 7, one end of support arm620 is coupled to distal guide member 616 in a manner that allows it toextend in the distal direction when capture member 602 is released fromcatheter 122. Likewise, in the embodiment shown, one end of support arm620 a is coupled to proximal guide member 618 in a manner that allows itto extend in the proximal direction when proximal capture member 604 isreleased from catheter 122. Endovascular device 600 can have any numberof support arms 620, 620 a. Further, support arms 620, 620 a can beslidably coupled to the respective guide members 616, 618 as describedabove with respect to support arms 120, 120 a. Other features discussedherein with respect to endovascular device 100, such as dimensions,materials, strand density, strand diameter, shape, position with respectto the blood vessel interior wall, coupling of guide members, radiopaquemarker, etc., are also applicable to endovascular device 600, and thusneed not be repeated.

According to another aspect of the present disclosure, there is a methodof removing one or more material deposits in a lumen, such as a clot ina blood vessel, using embodiments of the endovascular device of thepresent invention, such as device 100, device 400, or device 600. Whilethe disclosure may refer to numerical components of only one of device100, 400, or 600, it is understood that the discussion is applicable toother unmentioned device and its components. In one embodiment, anendovascular device according to aspects of the present invention, e.g.,device 100, 400, or 600, configured to match the conditions, e.g.,dimensions and shape, of the material deposit to be removed and thecorresponding lumen conditions is selected.

Referring to FIG. 8A, catheter 122 is provided to deliver endovasculardevice 100, 400, or 600 to the site of the obstruction, or clot 114, inlumen 128. Catheter 122 can be referred to as a delivery catheter. Inone embodiment, catheter 122 is a fluoroscopy microcatheter sovisualization methods known to those skilled in the art, such asfluoroscopy, can be used to assist in delivering catheter 122 to thedesired location. Catheter 122 is inserted into a patient's vessel andmoved to clot 114 using means known to those skilled in the art, such asusing another catheter, guide catheter 126, as shown in FIGS. 1A-1C. Insuch an embodiment, catheter 122 containing the endovascular device isadvanced through the patient's body in guide catheter 126. As catheter122 approaches clot 114, it naturally gravitates near the inner wall oflumen 128. In a preferred embodiment, tip portion 130 of catheter 122 ismoved distally through clot 114 to place tip portion 130 at a positiondistal to clot 114. In a preferred embodiment, catheter 122 navigates toclot 114 without endovascular device 100, 400, or 600 therein; however,catheter 122 with endovascular device 100, 400, or 600 can travel toclot 114 together. After catheter 122 is at a desired position,endovascular device 100, 400, or 600 is inserted into the lumen ofcatheter 122 in a compressed or collapsed configuration and can be movedthrough catheter 122 to arrive at clot 114. In a preferred embodiment,endovascular device 100, 400, or 600 comprises flexible material thatallows it to conform to catheter 122 as it makes its way throughpotentially tortuous paths without sustaining damage.

In a preferred embodiment, when the distal end of endovascular device100, 400, or 600 approaches tip portion 130, device 100, 400, or 600 isstabilized or steadied by manipulating the respective guide members(e.g., 116, 118) to place the respective capture members (e.g., 102,104) in the desired positions and holding the guide members (e.g., 116,118) together in place to maintain those positions. Referring to FIGS.4A-4B and 8B, catheter 122 is then slowly withdrawn to release orunsheathe the distal capture member (e.g., 102, 402, or 602) at aposition distal to clot 114. When released, the distal capture member(e.g., 102, 402, or 602) expands to gently touch the inner lining of thevessel wall to open the respective body member (e.g., 110, 410, or 610)to receive clot material. Non-limiting exemplary manners of expansion,such as through self-expanding material or mechanical expansion,including using inflatable members, are described above. In a preferredembodiment, the expansion of the distal capture member (e.g., 102, 402,or 602) is preferably achieved with the expansion of its frame component(e.g., 112 412, or 612), and/or body component (e.g., 110, 410, or 610)to the original or expanded configuration. The distal guide member(e.g., 116, 416, or 616) is preferably stabilized, steadied, or held inplace to maintain the distal capture member (e.g., 102, 402, or 602) inthe desired position distal to clot 114. Catheter 122 and the proximalguide wire (e.g., 118, 418, or 618) are then preferably held together sotheir movement are coupled to each other. Catheter 122 and the proximalguide wire (e.g., 118, 418, or 618) are then preferably moved in theproximal position together as a unit to place the proximal capturemember (e.g., 104, 404, or 604) at a location proximal to clot 114. Oncethe proximal capture member (e.g., 104, 404, or 604) is in a desiredlocation, the proximal guide member (e.g., 118, 418, or 618) is thenpreferably coupled or held with the distal guide member (e.g., 116, 416,or 616) to stabilize both capture members, maintaining them at therespective positions distally and proximally to clot 114.

Next, referring to FIGS. 1A and 8C, catheter 122 is further withdrawn tounsheathe or release the proximal capture member (e.g., 104, 404, or604), which expands in a similar manner as the distal capture member(e.g., 102, 402, or 602) as described above when released from the lumenof catheter 122, to a position proximal to clot 114. In one embodiment,the coupling angle between the frame component (e.g., 112, 412, or 612)and the respective guide member (e.g., 116, 118; 416, 418; or 616, 618)can be increased and decreased by adjusting the position of therespective supporting arm (e.g., 120, 120 a; or 420, 420 a; or 620, 620a). This can be achieved by applying force to the fastening memberslidably coupled to the respective guide member as described above inthe desired direction, i.e., proximally or distally.

Referring to FIGS. 1B, 4C, and 8D, both guide members (e.g., 116, 118;416, 418; or 616, 618) are manipulated to bring the capture members(e.g. 102, 104; 402, 404; or 602, 604) together. As shown in FIGS. 1B,4C, and 8D, frame components (e.g., 112, 412, or 612) of the capturemembers begin to engage the outer surface of the respective side of clot114. In one embodiment, the dislodging of clot 114 can be further aidedby repetitively moving at least one capture member (e.g. 102, 104; 402,404; or 602, 604) against clot 114. This can be done by repetitivemoving of the respective guide member itself and/or repetitive moving ofthe fastening member slidably coupled to that guide member. The effectis to gently separate clot 114 from the wall of lumen 128 before pullingthe capture members over separated clot 114, which allows for easierencapsulation of clot 114.

In one embodiment, proximal capture member (e.g., 104, 404, or 604)remains in one position while the distal capture member (e.g., 102, 402,or 602) is moved via manipulation of the distal guide member (e.g., 116,416, or 616) to engage the distal end of clot 114 and bring clot 114into both capture members (e.g. 102, 104; 402, 404; or 602, 604). Thedistal guide member (e.g., 116, 416, or 616) is preferably continued tobe withdrawn or pulled until the frame component (e.g., 112, 412, or612) of the distal capture member (e.g., 102, 402, or 602) unites orengages with the frame component (e.g., 112, 412, or 612) of theproximal capture member (e.g., 102, 402, or 602). Alternatively, forembodiments using frame components (e.g., 112, 412, or 612) of differentdiameters, the distal guide member (e.g., 116, 416, or 616) ispreferably continued to be withdrawn or pulled until the capture members(e.g. 102, 104; 402, 404; or 602, 604) join one another. In anotherembodiment, the distal capture member (e.g., 102, 402, or 602) is keptin place while the proximal capture member (e.g., 104, 404, or 604) ispushed in the distal direction toward the distal capture member (e.g.,102, 402, or 602) to engage the proximal end of clot 114 and bring clot114 into both capture members (e.g. 102, 104; 402, 404; or 602, 604)through manipulation of the proximal guide member (e.g., 118, 418, or618). In yet another embodiment, both capture members (e.g. 102, 104;402, 404; or 602, 604) can be moved toward one another, throughmanipulations of both guide members (e.g., 116, 118; 416, 418; or 616,618) to engage the respective side of clot 114. If equipped with suctioncapabilities, suctioning force can be applied when desired to furtherhelp direct clot 114 into either capture member (e.g. 102, 104; 402,404; or 602, 604).

Referring to FIGS. 1C, 4D, and 8E, once all or substantially all of clot114 is captured in the enclosure formed by capture members (e.g. 102,104; 402, 404; or 602, 604), clot 114 can be removed by holding guidemembers (e.g., 116, 118; 416, 418; or 616, 618) together so they canremain united with one another as a unit and be withdrawn together withclot 114 contained therein. Referring to FIG. 2, capture members (e.g.102, 104; 402, 404; or 602, 604) can be pulled through a stretch ofblood vessels as a unit containing clot 114 before device 100, 400, or600 enters catheter 126, as shown in FIGS. 3 and 5, for removal from thepatient's body. As shown in FIG. 2, the flexibility of certainembodiments of the components according to certain aspects of theinvention allow device 100, 400, or 600 to conform to tortuous paths ina patient's body without inflicting additional damage as it is pulledout of the patient. Alternatively or in addition to, referring to FIG.8F, device 100, 400, or 600, along with clot 114, can be withdrawn intocatheter 122 for removal, where catheter 122 has a diameter smaller thanthe diameter of frame component 112 in the expanded configuration,thereby compressing clot 114.

As described, certain embodiments of the present invention provide foran endovascular device containing less overall metal material, makingthe device more flexible with smaller profile, which is particularlyapplicable to ease of navigation in small and torturous braincirculation. Certain embodiments with less metallic material alsoprovide less trauma to the lining of the small and fragile brain bloodvessels during insertion and removal. The shape and size of the capturemembers of certain embodiments allow for better entrapment of theobstruction without significant compression of deformation which meanless fragmentation or pushing into normal side branch. In certainembodiments, the coupling of the frame component to the respective guidemember leaves the open end of the capture member unobstructed, givingmore space for the clot material to enter the capture member.

Although the embodiments of the present disclosure and their advantageshave been described in detail, it should be understood that variouschanges, substitutions and alterations can be made herein withoutdeparting from the spirit and scope of the invention as defined by theappended claims. Moreover, the scope of the present application is notintended to be limited to the particular embodiments of the process,machine, manufacture, composition of matter, means, methods and stepsdescribed in the specification. As one of ordinary skill in the art willreadily appreciate from the present disclosure, processes, machines,manufacture, compositions of matter, means, methods, or steps, presentlyexisting or later to be developed that perform substantially the samefunction or achieve substantially the same result as the correspondingembodiments described herein may be utilized according to the presentdisclosure. Accordingly, the appended claims are intended to includewithin their scope such processes, machines, manufacture, compositionsof matter, means, methods, or steps.

1. A device to remove an obstruction in a lumen comprising: a firstcapture member a second capture member; each capture member comprises anopen end and a tapered end, wherein said open end is defined by a framecomponent coupled to a body component, said body component extendingbetween said open end and said tapered end; a first guide member coupledto said first capture member at said open end, wherein at least aportion of said body component is attached to the first guide member; asecond guide member coupled to said second capture member at said open,wherein at least a portion of said body component is attached to thesecond guide member; and wherein said first capture member and saidsecond capture member are slidably coupled to each other, said slidablecoupling comprises said first guide member disposed in said second guidemember.
 2. The device of claim 1 further comprising: a radiopaquemarker.
 3. The device of claim 1 wherein said frame component isconfigured to fit within a catheter for delivery to said obstruction andto expand to define the open end when released from the catheter, saidcatheter having a radius smaller than a radius of the open end.
 4. Thedevice of claim 3 wherein said frame component comprises aself-expanding material configured to have an original configuration anda deformed configuration; wherein said self-expanding material isconfigured to change from said deformed configuration to said originalconfiguration at least by exposure to an activating condition.
 5. Thedevice of claim 4 wherein the deformed configuration allows the deviceto fit within the catheter.
 6. The device of claim 1 wherein the bodycomponent is attached to the respective guide member substantially alongthe length of the body component.
 7. The device of claim 1 wherein atleast one capture member further comprises a support arm coupled to therespective guide member and the respective frame component.
 8. Thedevice of claim 7 wherein said support arm comprises a first end and asecond end, wherein the first end is coupled to the respective framecomponent and the second end is coupled to the respective guide member.9. The device of claim 8 wherein the second end is attached to therespective guide member.
 10. The device of claim 7 wherein therespective guide member further comprises a fastening member slidablycoupled to said respective guide member and wherein the second end isattached to said fastening member.
 11. The device of claim 1 wherein thebody component is devoid of any fenestrations.
 12. The device of claim 1wherein the body component comprises a woven material of at least one ofthe following: a polymer, a metal, and any combination thereof.
 13. Thedevice of claim 1 wherein the body component comprises a soft andflexible material.
 14. The device of claim 1 wherein the body componentcomprises a self-expanding material configured to bias the bodycomponent into an expanded configuration.
 15. The device of claim 1wherein the body component covers at least a portion of a surface of theframe component to which the body component is coupled.
 16. The deviceof claim 1 wherein at least one guide member is adapted to provide asuctioning force.
 17. The device of claim 1 wherein the diameter of oneframe component is smaller than the diameter of the other framecomponent.
 18. The device of claim 1 wherein at least one framecomponent comprises an inflatable member.
 19. The device of claim 1further comprises an inflatable member disposed near at least one framecomponent.
 20. The device of claim 1 wherein at least one guide membercomprises a body with a channel disposed therein, said body having atleast one aperture positioned near an end near the respective capturemember.
 21. The device of claim 20 wherein the at least one guide memberis used to provide a suctioning force.
 22. The device of claim 21wherein the at least one guide member is used to deliver a therapeuticsubstance to said obstruction.
 23. The device of claim 1 wherein thecoupling between at least one guide member and the respective framemember comprises the at least one guide member attached to an outersurface of the respective frame member.
 24. A method for removing anobstruction in a lumen comprising: delivering an endovascular device tothe location of the obstruction in a patient using a catheter, saiddevice comprises: a first capture member a second capture member; eachcapture member comprises an open end and a tapered end, wherein saidopen end comprises a frame component coupled to a body component, saidbody component extending between said open end and said tapered end; afirst guide member coupled to said first capture member at said open endand along at least a portion of said body component; a second guidemember coupled to said second capture member at said open end and alongat least a portion of said body component; wherein said first capturemember and said second capture member are slidably coupled to eachother, said slidable coupling comprises said first guide member disposedin said second guide member; positioning a distal end of the catheterdistal to said obstruction; withdrawing said catheter to release thefirst capture member distal to said obstruction; positioning the distalend of the catheter proximal to said obstruction; withdrawing saidcatheter to release the second capture member proximal to saidobstruction; enclosing said obstruction with said capture members bymanipulating at least one of the first guide member or the second guidemember to unite the capture members; and removing said capturedobstruction by removing said united capture members from the lumen. 25.The method of claim 24 further comprising the step of providing asuctioning force through at least one guide member.
 26. The method ofclaim 24 further comprising the step of repeatedly moving at least oneframe member against the obstruction.
 27. The method of claim 24 furthercomprising the step of delivering a therapeutic substance to saidobstruction.
 28. The method of claim 27 wherein said delivering isachieved at least through one of said guide members, said guide membercomprising a body with a channel disposed therein, said body having atleast one aperture positioned near an end near the respective capturemember.
 29. The method of claim 24 wherein the enclosing step comprisesmanipulating the first guide member to engage a surface of the firstcapture member with a surface of the obstruction while the second guidemember is maintained stationary.
 30. The method of claim 24 wherein theenclosing step comprises manipulating the second guide member to engagea surface of the second capture member with a surface of the obstructionwhile the first guide member is maintained stationary.
 31. The method ofclaim 24 wherein the enclosing step comprises manipulating both thefirst and second guide members to engage a surface of both capturemembers with a surface of the obstruction.